Scientist / Senior Scientist CMC (TK19-204)

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel treatments for hemophilia and other rare bleeding disorders using our potent, subcutaneous (SQ) coagulation factors that promote prophylaxis therapy. We have completed the Phase 2 trial of our subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis. The study met the primary endpoint of significantly reducing the annualize bleed rate (ABR) in patients with hemophilia A or B with inhibitors. The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation. We have also initiated enrollment in a Phase 2b trial of dalcinonacog alfa – DalcA, a next-generation (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.

We are currently seeking to hire a motivated Scientist or Senior Scientist with Drug Substance and Drug Product experience to join our CMC team. The ideal Scientist or Senior Scientist will play a key role in the planning, coordination, and execution of drug substance and drug product development.

Collaborate with internal and external stakeholders to support project plans and schedules; ensuring that tasks are executed in accordance with operational plans, cGMP requirements and regulatory commitments

Participate in preparation and review of CMC sections of regulatory filings

Provide trouble-shooting support as well as root cause analysis

Liaison for all 3rd party CMOs and CROs

Write and review batch record analysis and interpretations

Travel globally as required to CMO, CRO and key vendor sites to represent Catalyst Biosciences for Manufacturing oversight and partnership development purposes

Qualifications/Skills Required

PhD in a scientific discipline with a minimum of 5 years’ experience in a development environment, MSc with a minimum of 10 years’ experience or exceptional BSc candidates with a minimum of 15 years relevant of experience will also be considered

Technical expertise in development and full-scale manufacture of recombinant mammalian biologic products